Labelling error may lead to patients receiving Linessa 28 birth control pills instead of Linessa 21

Health Canada is advising Canadians of a labelling error affecting one lot of Linessa 28 birth control pills on the Canadian market (lot 190056, expiry 06/2021).

The English side of Linessa 28 boxes is incorrectly labelled with the eight-digit Drug Identification Number (DIN) for Linessa 21 (02272903) instead of the correct Linessa 28 DIN (02257238). The labelling error could result in a Linessa 21 patient inadvertently receiving Linessa 28 instead of Linessa 21 if the product is dispensed at the pharmacy only using the incorrect DIN as a reference.

There is a small chance that patients who were prescribed Linessa 21 but received Linessa 28 in error may not know that the last 7 green "reminder" pills in the Linessa 28 pack are inactive pills that do not contain any hormones. If patients take a "break" week (no pills) after completing a 28-day pack, as is the practice with Linessa 21, this would result in two weeks without hormone treatment, which could increase the risk of pregnancy.

The DIN error affects the English side of Linessa 28 boxes only. The French side of Linessa 28 boxes has the correct DIN. The product name "Linessa 28" is clearly and accurately printed on the box, the foil pouch and the blister pack.